The CAP-1 Trial: Stepwise Excavation Versus One Completed Excavation in Deep Caries
This study is currently recruiting patients
Verified by University of Copenhagen February 2006
|University of Copenhagen
National Health Insurance foundation
Dan Dental, Denmark
University of Aarhus
Gothenborg University, Sweden
Huddinge Faculty, Stockholm, Sweden
Uppsala FolkTandvård, Sweden
Malmö Dental school, Sweden
|Information provided by:
||University of Copenhagen
A large proportion of dental practice involves the treatment of caries in the permanent dentition. In USA alone tooth related pain is annually responsible for 15 billions days lost through sickness. We do not know whether a stepwise excavation is better or worse compared with one final completed excavation in adults with deep caries with or without pain. A deep carious lesion is in the risk zone of being pulpal exposed during excavation.
The aim of the CAP-1-trial is to investigate the beneficial effects of stepwise excavation during two visits versus óne completed excavation of deep caries in permanent teeth with or without pain.
Consecutive patients contacting the units involved in the CAP trial for the treatment of deep caries. The trial will comprise 300 patients.
CAP-1-trial is a randomised patient- and observer-blinded multicenter trial, with two parallel intervention groups. Patients that fulfill the inclusions criteria and none of the exclusions criteria, will be centrally bloc-randomised in Copenhagen Trial Unit, Copenhagen DK, and stratified by age and pain. Allocation ratio is 1:1.
Interventions and products:
Patients are allocated for stepwise excavation in two visits or final excavation in one visit. The patients will not be informed about the result of the randomisation, i.e. the type of intervention. Therefore, all patients will be contacted for two visits. The second visit in the stepwise excavation group wil be used for the second and final excavation, and for the performance of a permanent restoration. The second visit in the one step excavation group will solely be used for the performance of a permanent restoration. The interventions in both groups are completed following 8-10 weeks after the randomisation.
A temporary calcium hydroxide based material is used in both groups (Dycal®). The temporary restoration material, glas-ionomer cement is used (Ketac Molar®) in between visits, and a resin material is used for the final restoration (Herculite®).
|Deep Caries Lesions
|Procedure: Stepwise Excavation, one completed excavation
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: The CAP-1 Trial: Effect of Stepwise Versus One Completed Excavation in Deep Caries in Permanent Teeth: A Randomised, Patient
- and Observer-Blinded Multicenter Trial
Further study details as provided by University of Copenhagen:
Primary Outcomes: Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following
a 1-year control.
Secondary Outcomes: Secondary outcome constitutes pain intensity using a visual analogue scale measured before the first visit and 1 and 7 days
Expected Total Enrollment:
Study start: February 2005;
Expected completion: April 2008
Last follow-up: December 2007;
Data entry closure: February 2008
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Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
- Person ≥ 18 yrs having deep caries with or without pain:
- x-ray show primary caries in the inner 1/4 of the dentin, with the presence of a radiopaque zone at the pulpal wall NB: Need
to mark a 'yes' for both criteria!
- Deep carious tooth with (irreversible pulpitis)unbearable pain and/or disturbed night's sleep)
- Deep carious tooth negatively responding on thermal and electrometric tests.
- Deep carious tooth has ’attachment loss’ > 5 mm
- X-ray shows apical radiolucency of the actual tooth
- Deep carious tooth has restoration in direct contact with the pulp
- The person has problems with communication
- No informed and written consent is present
- Due to health conditions or pregnancy the person can not participate in the trial
NB: Need to mark 'No' for all criteria
Please refer to this study by ClinicalTrials.gov identifier
Denmark, Copenhagen N
School of Dentistry, Faculty of Health Sciences, Copenhagen,
Study chairs or principal investigators
Lars Bjørndal, Study Director, University of Copenhagen
Study ID Numbers:
February 8, 2006
Record first received:
September 9, 2005
Health Authority: Denmark: National Board of Health; Sweden: Ethic Committee, Gothenborg University
ClinicalTrials.gov processed this record on 2006-09-29